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Assessment of medicinal products

Assessment of medicinal products at HAS

HAS is responsible for providing recommendations, largely with regards to reimbursement of medicinal products; the latter falling within the jurisdiction of the HAS Transparency Committee (TC).

> To learn more about the medicinal product assessment process at HAS

> To submit an assessment file for a medicinal product (in French only)

> To consult the guidance for submission and proceeding of an early dialogue at the national level (with HAS) or at the European level (with EMA and/or other HTA bodies)

 

Recommendations on medicines

The TC recommendations are nonbinding and do not predict the Ministers decisions in terms of reimbursement.

A recommendation generally includes:

  • an evaluation of the actual clinical benefit (ACB) to ensure legitimate listing of a medicinal product;
  • a comparison of the actual clinical benefit (ACB) of a medicinal product with that of the reference therapeutic class;
  • an evaluation of the clinical added value (CAV) provided by a medicinal product in relation to its comparators;
  • a re-evaluation of the added clinical value (CAV) of a medicinal product for listing renewal.

> See the TC recommendations on medicinal products

Posted on Oct 29 2015